Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer (HARVEST)
A Prospective Adaptive Pilot Study of Serial Unstimulated Oocyte Retrieval and CAPA-IVM (Capacitation In Vitro Maturation) for Euploid Embryo Accumulation in Women With Robust Ovarian Reserve
This study is testing whether eggs can be collected from small follicles without using the usual ovarian stimulation medications. Participants will have up to three egg retrieval procedures. The eggs collected during each retrieval will be matured in the laboratory using the CAPA-IVM (Capacitation In Vitro Maturation) process, fertilized, grown into embryos, and tested to identify chromosomally normal embryos.
Embryos from the retrievals may be frozen and accumulated. If a suitable embryo is available, one chromosomally normal embryo may be transferred. The study will also monitor safety, hormone levels, follicle development, embryo development, pregnancy results, and how well participants tolerate the study procedures.
연구 개요
상태
정황
상세 설명
This is a single-arm, prospective, open-label, adaptive pilot study designed to evaluate the feasibility of serial unstimulated transvaginal oocyte retrieval followed by CAPA-IVM (Capacitation In Vitro Maturation) for euploid embryo accumulation in infertility patients with robust ovarian reserve.
Approximately 30 participants will be enrolled. Participants will undergo serial unstimulated transvaginal oocyte retrieval procedures targeting visible 4-9 mm antral follicles. Retrieved cumulus-oocyte complexes will undergo CAPA-IVM (Capacitation In Vitro Maturation), followed by intracytoplasmic sperm injection, blastocyst culture, preimplantation genetic testing for aneuploidy, and embryo vitrification/accumulation. Euploid embryos generated across retrievals will be accumulated for subsequent single euploid embryo transfer according to the protocol and site clinical practice.
The study will be conducted in two stages. Stage 1 will enroll approximately 10 participants using initially defined serial retrieval timing to evaluate feasibility, safety, follicle availability, and retrieval interval optimization. Following review of Stage 1 safety, feasibility, follicle emergence, and endocrine data, Stage 2 will enroll approximately 20 additional participants. Retrieval intervals in Stage 2 may be adjusted if supported by interim findings.
The study will summarize retrieval-specific and participant-level outcomes, including follicle counts, oocyte yield, oocyte maturation, fertilization, blastocyst development, PGT-A (Preimplantation Genetic Testing for Aneuploidy) results, euploid embryo yield, embryo accumulation, and progression to single euploid embryo transfer. Safety and tolerability will be assessed throughout the study, including procedure-related complications, anesthesia/sedation-related events, antibiotic-related reactions, retrieval deferrals or discontinuations, and other adverse events.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Kevin Doody, MD
- 전화번호: 817-924-1572
- 이메일: kevind@embryo.net
연구 장소
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Texas
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Bedford, Texas, 미국, 76104
- 모병
- CARE Fertility Texas
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수석 연구원:
- Kevin Doody, MD
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연락하다:
- Kevin Doody, MD
- 전화번호: 8179241572
- 이메일: kevind@embryo.net
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부수사관:
- Kathy Doody, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Signed informed consent.
- Female participant aged 18-35 years.
- Diagnosis of infertility requiring IVF/ICSI, including unexplained infertility or mild male factor infertility.
- BMI 18-30 kg/m².
- AMH ≥2.5 ng/mL.
- AFC ≥12.
- Basal FSH <8 IU/L.
- Ovaries accessible for transvaginal retrieval.
- Willing to undergo serial unstimulated TVORs with adaptive retrieval timing.
- Willing to undergo CAPA-IVM, ICSI, blastocyst culture, PGT-A, embryo vitrification/accumulation, and single euploid embryo transfer.
- Willing to undergo serial ultrasound and endocrine monitoring.
- Willing and able to comply with study procedures and follow-up.
Exclusion Criteria:
- Prior ovarian surgery.
- Ovarian endometrioma.
- Inaccessible ovaries.
- Significant uterine factor expected to compromise implantation, pregnancy, or live birth.
- Significant medical comorbidity that would increase risk of TVOR, pregnancy, or study participation.
- AMH <2.5 ng/mL.
- AFC <12.
- Basal FSH ≥8 IU/L.
- BMI <18 or >30 kg/m².
- Current smoking or nicotine use within 3 months of screening.
- Active pelvic infection, untreated STI, or acute urinary tract infection.
- Contraindication to transvaginal oocyte retrieval, anesthesia/sedation, pregnancy, or antibiotic prophylaxis.
- Known chromosomal abnormality in the participant or sperm source that would confound study outcome assessment.
- Severe male factor infertility requiring surgical sperm retrieval, unless specifically permitted by the final protocol.
- Recent exposure to teratogenic radiation, drugs, or toxins.
- Current participation in another interventional clinical trial that may confound outcomes.
- Previous participation in the CARE study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Interventional, single-arm, prospective, open-label, adaptive pilot study
Participants will undergo up to three unstimulated transvaginal oocyte retrievals targeting visible 4-9 mm antral follicles, without ovarian stimulation or ovulatory trigger medication.
Retrieved oocytes will undergo CAPA-IVM (Capacitation In Vitro Maturation), ICSI (Intracytoplasmic Sperm Injection), blastocyst culture, PGT-A (Preimplantation Genetic Testing for Aneuploidy), embryo vitrification/accumulation, and single euploid embryo transfer if a suitable embryo is available.
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The CAPA-IVM System Kit will be used in the laboratory to support collection, handling, capacitation, and maturation of immature cumulus-oocyte complexes retrieved from visible 4-9 mm antral follicles.
Participants will undergo up to three unstimulated transvaginal oocyte retrievals targeting visible 4-9 mm antral follicles, without exogenous gonadotropin stimulation or ovulatory trigger medication.
Retrieved oocytes will undergo CAPA-IVM followed by ICSI, blastocyst culture, PGT-A, embryo vitrification/accumulation, and single euploid embryo transfer if a suitable euploid embryo is available.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of euploid embryos per retrieval
기간: From first egg retrieval to final PGT-A results, approximately 4 weeks.
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Number of euploid embryos per retrieval, assessed by PGT-A (Preimplantation Genetic Testing for Aneuploidy), with each participant serving as her own control across serial retrievals.
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From first egg retrieval to final PGT-A results, approximately 4 weeks.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- CARE-2026-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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